Youth-Led Intervention to Improve Blood Pressure

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT05029687
Status
Completed

Conditions

  • Adolescent Behavior
  • Health Knowledge, Attitudes, Practice
  • Hypertension

Eligibility Criteria

Sex
ALL
Age
14 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Youth-Led Hypertension Education Digital Intervention — BEHAVIORAL
    The intervention is a youth-led HTN education digital intervention, which will be comprised of a 6-week playlist of one module per week comprising the playlist. Youth will learn from the module and will teach the adult in their dyad about hypertension education in each week's themed module.

Study Details

The proposed study will develop, test, and collect implementation data on a youth-led hypertension (HTN) education intervention, which will act as an electronic tool to guide youth through learning and then teaching adults on how to achieve better HTN control. Adults with HTN and youth will be recruited for user-centered design sessions to provide input in the development of a youth-led HTN education digital badge. The investigators will then recruit adult emergency department (ED) patients with uncontrolled HTN (blood pressure (BP) ≥130/80 mm Hg) who know (friend or family member) a youth (14-24 years old) and the youth themselves for a RCT. The adult plus youth dyad will be randomized to either: 1) intervention arm- 6-week youth-led HTN education digital badge at home- or 2) control arm- 6-week youth job readiness digital badge at home. In addition to the primary study outcome of adult BP change 2-months post-intervention, the investigator will collect secondary outcomes of HTN knowledge and youth self-efficacy, as well as implementation metrics of intervention acceptability, feasibility, and fidelity. Due to challenges recruiting youth through adults in the ED, we will be adding a cohort to the study where we will recruit interested youth from New Brunswick Health Sciences Technology High School (NBHSTHS). Specific aims are: Aim 1: Create a youth-led HTN education digital badge by means of user-centered design methods and community engagement with adults with HTN and youth to obtain input on the contents of the digital badge prior to implementation. Aim 1a: The hypertension knowledge assessment being used in the study has not been used before on youth or Spanish-speaking populations, so the investigators will obtain feedback on the assessment from these groups. Aim 2: Evaluate the effectiveness of a youth-led HTN education digital badge intervention on the primary outcome of mean systolic BP and diastolic BP change in adults with uncontrolled HTN at 2-months post-intervention compared to the control group (for participants recruited from the ED). Additionally, evaluate change in HTN knowledge and youth self-efficacy. Aim 3: Evaluate the implementation process of the youth-led HTN education digital badge by collecting qualitative and quantitative data on acceptability, feasibility, and fidelity of the intervention by participants.

Key Dates

Start date
Oct 31, 2021
Status verified
Dec 2025
Primary completion
Jun 30, 2023
Completion
Jun 30, 2023

Study Design

Enrollment
64 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention Arm
    The intervention is a youth-led HTN education digital intervention, which will be comprised of a 6-week playlist of one module per week comprising the playlist. Youth will learn from the module and will teach the adult in their dyad about hypertension education in each week's themed module.

Primary Outcome Measure

School Cohort: Hypertension Knowledge (Youth and Adult) [ Time Frame: At end of 6-week intervention, and 1 month post-6-week intervention ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rutgers Robert Wood Johnson Medical SchoolNew BrunswickNew Jersey08901-

Find similar trials in New Brunswick, NJ

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Rutgers Robert Wood Johnson Medical School· New Brunswick, NJ

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